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Zacks News
Novartis (NVS) to Buy Gyroscope, Submits Herceptin Biosimilar to EMA
by Zacks Equity Research
Novartis (NVS) is set to acquire ocular gene therapy company Gyroscope Therapeutic. Generic arm Sandoz submits a marketing authorization application for a proposed biosimilar of Herceptin.
ACADIA (ACAD) Up on Resubmission Plan for Nuplazid sNDA to FDA
by Zacks Equity Research
ACADIA (ACAD) to resubmit sNDA for Nuplazid (pimavanserin) to the FDA for treating hallucinations and delusions associated with dementia focused on Alzheimer's disease psychosis. Shares rise.
Sanofi (SNY) to Acquire Amunix, Boost Immuno-oncology Pipeline
by Zacks Equity Research
Sanofi (SNY) inks a deal to acquire privately-held Amunix Pharmaceuticals, which will add potentially transformative cancer therapies to its immuno-oncology pipeline.
Novartis (NVS) Collaborates With BeiGene for Oncology Drug
by Zacks Equity Research
Novartis (NVS) signs collaboration and license agreement with BeiGene for ociperlimab (BGB-A1217), expanding research and development activities in immuno-oncology.
Gilead's (GILD) Veklury Gets EC Nod for Use in Early COVID-19
by Zacks Equity Research
Gilead's (GILD) Veklury can now be used in the EU at the early stages of COVID-19 to help prevent disease progression in high-risk patients.
These 5 Loser Stocks of 2021 Could be Big Winners in 2022
by Anindya Barman
The momentum in the equity markets is expected to stay on firm-footing in 2022. DQ, PINS, SRPT, YY and CD have a chance to outperform next year.
Seagen (SGEN) Gets Positive CHMP Opinion for Bladder Cancer Drug
by Zacks Equity Research
The CHMP gives a positive opinion on, and recommends approval to Seagen's (SGEN) Padcev as a monotherapy for treating adult patients with locally advanced/metastatic urothelial cancer.
Pfizer (PFE) to Test 3-Dose COVID-19 Vaccine Regimen in Kids
by Zacks Equity Research
Pfizer (PFE) and BioNTech (BNTX) to evaluate a third, 3 ug dose at least two months after the second dose of Comirnaty in children aged six months to five years for better protection against COVID-19.
Global Blood (GBT) Gets FDA Nod for Oxbryta Label Expansion
by Zacks Equity Research
The FDA approves Global Blood's (GBT) sNDA for Oxbryta to treat SCD in children aged four to less the 12 years, and NDA for a pediatric weight-based formulation of the drug.
Vir (VIR), Glaxo's Xevudy Wins EC Approval for COVID-19
by Zacks Equity Research
Vir Biotechnology, Inc. (VIR) and partner GlaxoSmithKline obtain the European Commission's nod for Xevudy for the early treatment of COVID-19.
Emergent (EBS) Begins Dosing in Study on Influenza Vaccine
by Zacks Equity Research
Emergent (EBS) initiates a phase I study evaluating EBS-UFV-001, the company's investigational universal influenza vaccine candidate.
uniQure (QURE) Falls on Data From Huntington's Disease Study
by Zacks Equity Research
uniQure (QURE) reports initial data on the first four patients enrolled in the lower-dose cohort of its ongoing phase I/II clinical trial of AMT-130 for treating Huntington's disease.
Bristol Myers' (BMY) Orencia Gets FDA Nod for New Indication
by Zacks Equity Research
The FDA approves Bristol Myers' (BMY) Orencia in combination with a calcineurin inhibitor and methotrexate to prevent acute graft versus host disease. This is the fourth FDA-approved indication for the drug.
Apellis (APLS), Sobi Get EU Nod for Rare Blood Disorder Drug
by Zacks Equity Research
The European Commission approves Apellis (APLS) and Sobi's Aspaveli for the treatment of paroxysmal nocturnal hemoglobinuria in adult patients. Shares rise.
Calliditas' (CALT) Tarpeyo Wins FDA Approval for Renal Disease
by Zacks Equity Research
Calliditas (CALT) obtains accelerated approval for Tarpeyo to reduce proteinuria in IgA nephropathy in the United States.
Alnylam (ALNY) Files for Oxlumo Label Expansion in US & EU
by Zacks Equity Research
Alnylam (ALNY) files regulatory applications to the FDA and the EMA, seeking approval for a new indication of Oxlumo for the treatment of advanced primary hyperoxaluria type 1.
Trevena (TRVN) to Begin Clinical Study on Pain Candidate
by Zacks Equity Research
Trevena (TRVN) advances TRV045 into clinical development as a potential treatment for diabetic neuropathic pain. Enrollment in the study is expected to begin in the first quarter of 2022.
Foghorn (FHTX) Surges on Oncology Collaboration With Lilly
by Zacks Equity Research
Foghorn (FHTX) soars following a collaboration with pharma giant Lilly for novel oncology targets.
Bristol-Myers (BMY) Up on Dividend Hike, Share Repurchase
by Zacks Equity Research
Bristol-Myers (BMY) increases its quarterly dividend and announces a share repurchase program. Consequently, the stock gains.
Pfizer (PFE) to Buy Arena, Boost Immuno-Inflammatory Pipeline
by Zacks Equity Research
Pfizer (PFE) signs an agreement to acquire Arena Pharmaceuticals for $6.7 billion in cash. Stock rises.
Forma's (FMTX) Etavopivat Proves Safety Profile in SCD Study
by Zacks Equity Research
Forma's (FMTX) investigational PKR activator, etavopivat significantly improves anemia and red blood cell health in patients with sickle cell disease.
Moderna's (MRNA) Flu Vaccine Data Fails to Impress Investors
by Zacks Equity Research
Moderna's (MRNA) early-stage flu vaccine data seems promising but it fails to meet investors' expectations.
Cytokinetics' (CYTK) Aficamten Gets Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy status on Cytokinetics' (CYTK) aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
Intercept (ICPT) Down on Withdrawal of Application for NASH
by Zacks Equity Research
Intercept (ICPT) withdraws its application seeking approval for OCA for the treatment of liver fibrosis due to nonalcoholic steatohepatitis in the EU. Resultantly, the stock declines.
Aytu BioPharma's (AYTU) AR101 Gets FDA's Orphan Drug Status
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Aytu BioPharma's (AYTU) AR101 for the treatment of vascular Ehlers-Danlos Syndrome.